- 6/7/20 - 1 form, 4 itemgroups, 31 items, 1 language
Itemgroups: Administrative Data, Eligibility Question, Inclusion Criteria, Exclusion Criteria
- 6/7/20 - 1 form, 8 itemgroups, 91 items, 1 language
Itemgroups: Administrative Data, 12-Lead ECG Abnormalities, Rhythm, P-Wave Morphology, Conduction, Myocardial Infarction, Depolarisation/Repolarisation (QRS-T), ECG, Other abnormalities
- 5/26/20 - 1 form, 6 itemgroups, 45 items, 1 language
Itemgroups: Administrative Data, Mother's relevant medical/family history, Father's Relevant Medical/Family History, Drug Exposures, Subject withdrawal, Reporting Investigator Information
Study ID: 103933 Clinical Study ID: NKV103933 Study Title: A non-randomised, open label, two period cross-over study to determine the excretion balance and metabolic disposition of [14C]-GW679769, administered as single doses of an oral solution and an intravenous infusion to healthy male subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced Protocol ID: NKV103933 The eligibility to participate was determined during a screening visit within 21 days prior to first dosing day. The study consisted of two dosing periods, each consisting of predose visit, monitoring after dose administration and prior to discharge visit. Dosing periods were separated by a wash-out period of 43 days. The Pregnancy Notification Form is used to report pregnancy to GSK in specific cases specified by the Protocol. This form should be completed according to the protocol reporting requirements. Complete this form for each subject or subject’s partner who becomes pregnant during the study period. Send a copy of the form to GlaxoSmithKline (GSK will provide separately a list of contact names and information) by mail or fax (fax preferred) within two weeks of learning of the pregnancy. Original pages should remain with the subject’s Case Report Form. Note: This form does not routinely need to be completed for subject’s partner pregnancy unless there is specific instruction to do so stated in the protocol.
- 5/26/20 - 1 form, 5 itemgroups, 12 items, 1 language
Itemgroups: Administrative Data, consent Pharmacogenetic Test, BLOOD SAMPLE COLLECTION, WITHDRAWAL OF CONSENT, BLOOD SAMPLE DESTRUCTION
- 5/26/20 - 1 form, 3 itemgroups, 8 items, 1 language
Itemgroups: Administrative Data, Investigator Comment Log, Investigator's Signature
- 5/24/20 - 1 form, 5 itemgroups, 29 items, 1 language
Itemgroups: Administrative Data, Pharmacokinetics - Blood, Metabolite Profiling - Plasma, Metabolite Profiling - Urine, Metabolite Profiling - Faeces
- 5/24/20 - 1 form, 16 itemgroups, 67 items, 1 language
Itemgroups: Administrative Data, Serious Adverse Event, SECTION 1, SECTION 2: Seriousness, SECTION 3 Demography Data, SECTION 4 If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?, SECTION 5 Possible Causes of SAE Other Than Investigational Product(s), SECTION 6 RELEVANT Medical Conditions, SECTION 7 Other RELEVANT Risk Factors, SECTION 8 RELEVANT Concomitant Medications, SECTION 9 Details of Investigational Product(s) - Treatment Period 1, SECTION 9 Details of Investigational Product(s) - Treatment Period 2, SECTION 10 Details of relevant Assessments, SECTION 11 Narrative Remarks, Investigator's name and signature, SECTION 12: Additional/Follow-Up Information